The Inova Type 2 Diabetes Mellitus Study

Diabetes, Type 2 Clinical Trial

— InovaDM2  

Official title:

Insulin Glargine vs NPH as Basal Insulin on Glycemic Values in Hospitalized Patients: The Inova Diabetes Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02222623
• Other study ID #: 14-1623
• Status: Withdrawn
• Phase: N/A
• First received: August 19, 2014
• Last updated: August 3, 2016
• Start date: April 2015
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety and effectiveness of the two different basal insulins commonly used for basal blood sugar control in the treatment of type 2 diabetes mellitus in patients who are hospitalized and require low doses of insulin: neutral protamine Hagedorn (NPH) insulin and glargine (Lantus®) insulin. Previous research has shown that both NPH insulin and glargine (Lantus®) insulin is safe and effective for the control of blood sugar in a type 2 diabetic patient. This research is being done because the costs of medications for diabetic patients are very expensive. Our goal with this research is to show that a less expensive insulin (NPH) is as safe and effective as a more expensive insulin [glargine (Lantus®)] in patients with type 2 diabetes mellitus who are in the hospital.

Description:

This is a randomized, open label trial comparing effectiveness of insulin glargine and insulin NPH in a basal plus correctional regimen. Patients will be randomized to either an intervention (NPH) or a control group (glargine) upon admission. The following data will be collected: age, sex, weight, preadmission diabetes medications, admission diagnosis, HbA1C, blood glucose (BG), chemistry, hematology, urine analysis, pregnancy test, duration of hospitalization, insulin dose, and discharge status. Data will be recorded and maintained confidentially.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Adult patients ages18-75 admitted to a general medicine or surgical Department of Medicine hospitalist services.

2. A known history of T2DM, receiving either diet alone, low dose insulin (=0.4 units/kg/day), OADs, GLP1 analogs, or in any combination of OADs, GLP1 analogs and low dose insulin (=0.4 units/kg/day).

3. Subjects must have a BG >140 mg/dL and =240 mg/dL before randomization without laboratory evidence of diabetic ketoacidosis or hyperglycemic hyperosmolar nonketotic syndrome (bicarbonate <18 mEq/L, pH <7.30, or positive serum or urinary ketones, BG >240 mg/dL).

Exclusion Criteria:

1. Patients with a diagnosis of type 1 diabetes mellitus.

2. Patients using nutritional bolus insulin at home.

3. Patients with increased blood glucose concentration, but without a known history of diabetes.

4. Patients with a history of diabetic ketoacidosis, hyperglycemic hyperosmolar nonketotic syndrome, or ketonuria.

5. Patients admitted to or expected to require admission to any intensive care unit (ICU) or intermediate care unit (IMC).

6. Patients who are receiving or are anticipated to receive enteral or parenteral nutrition.

7. Patients admitted for cardiac surgery.

8. Patients receiving continuous insulin infusion.

9. Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (creatinine = 3.5 mg/dL).

10. Persons with decisional incapacity (mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study).

11. Female subjects who are pregnant or immediately (same hospitalization) post partum at time of enrollment into the study.

12. Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Type 2

Intervention

Drug:
• Glargine
Glargine given as 100% total daily dose with breakfast. The initial dose will be calculated using the patient's weight or using their basal insulin doses prior to hospitalization.
• NPH
NPH 2/3 of the total daily dose given with breakfast, 1/3 of the total daily dose given at bedtime. The initial dose is calculated using the patient's weight or using the basal insulin dose prior to hospitalization.

Locations

Country	Name	City	State
United States	Inova Fairfax Hospital	Falls Church	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Inova Health Care Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean total daily dose of insulin		5 days	No
Other	Length of hospital stay		within first 30 days of admission	No
Primary	Mean daily blood glucose		5 days	No
Secondary	Percent of total BG readings within target BG 70-180 mg/dL before meals.		5 days	No
Secondary	Number (Percent) of episodes and total BG readings of hypoglycemic events (BG < 70 mg/dL)		5 days	Yes
Secondary	Number (Percent) of total BG readings of severe hyperglycemia (BG > 300 mg/dL) after the first day of treatment.		5 days	Yes
Secondary	Hospital mortality		5 days	Yes